Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)
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|ClinicalTrials.gov Identifier: NCT04326023|
Recruitment Status : Completed
First Posted : March 30, 2020
Last Update Posted : March 11, 2021
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.
The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.
|Condition or disease||Intervention/treatment|
|Cancer||Drug: PARP Inhibitors|
|Study Type :||Observational|
|Actual Enrollment :||178 participants|
|Official Title:||Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO and the French Pharmacovigilance Databases (MyeloRIB)|
|Actual Study Start Date :||February 9, 2020|
|Actual Primary Completion Date :||March 18, 2020|
|Actual Study Completion Date :||May 3, 2020|
- Drug: PARP Inhibitors
olaparib, rucaparib, niraparib, talazoparib, veliparib
- MDS/AML reports related to PARPi (from WHO database). [ Time Frame: From inception to May 3, 2020 ]Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the World Health Organization (WHO) database of individual safety case reports.
- MDS/AML reports related to PARPi (from French database). [ Time Frame: From inception to May 1, 2021 ]Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the French pharmacovigilance database of individual safety case reports. The aim is to describe clinical features of these rare adverse events, including bone marrow analyzes, cytogenetic and molecular abnormalities, blasts immunophenotyping anonymously reported in this database.
- Description of the median time to onset since first PARPi exposure. [ Time Frame: From inception to May 3, 2020 ]
- Description of the fatality rate. [ Time Frame: From inception to May 3, 2020 ]
- Description of patients who experienced co-reported adverse events. [ Time Frame: From inception to May 3, 2020 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04326023
|Caen, Basse Normandie, France, 14000|